Senior Plant Engineer Pharmaceutical
Company: Grimaldi Staffing Services
Location: Fremont
Posted on: August 6, 2022
Job Description:
As Process Engineer, Sr Process Engineer in a pharmaceutical GMP
environment, you will participates in design review and
implementation for all projects, process engineering,
refurbishment/replacement and life cycle cost analysis for the Drug
Substance/Drug Product process and equipment. Leveraging your
background in Chemical or Mechanical engineering, you will provide
engineering support for drug substance related maintenance,
engineering and calibration management programs. This position
troubleshoots operations of the process & facilities equipment and
utilities as needed. You will develop, establish and maintain
quality-engineering methodologies, systems, and practices which
meet internal and regulatory requirements. You will also provide
focused quality engineering support for the Facilities department
on new construction, facility upgrades/retrofits/modernizations,
and facilities equipment.Essential Duties/Responsibilities
- Perform design review and construction management for
projects
- Perform in-house design and manages facilities engineering and
construction projects
- Manage the installation and repair of infrastructure of Drug
substance and Drug product process equipment as well as related
environments. This includes fillers, cappers, Lyophilizers, closed
RABs, vial washers, inspection and labeling equipment
- Support the installation, maintenance, operation, and
adjustments made to the process equipment, and related utilities
such as pumps, boilers, air handling units, air compressors,
chillers, clean steam, and USP Purified Water systems
- Collaborate with manufacturing departments to ensure compliance
activities are executed efficiently and effectively, and in
accordance with all governing documents and regulatory
guidelines
- Serve as a subject matter expert (SME) in support of drug
substance and drug product related facilities equipment and
projects
- Develop, mentor, and train personnel and internal customers on
relevant business processes
- Contribute to continuous quality improvement efforts to conform
to regulatory requirements and industry standards.
- Track, trend and analyze utility data
- Support negotiations and management of technical facility
maintenance contracts
- Support management and oversight of scheduled preventative
maintenance on a wide variety of process equipment and support
utilities
- Cross Train in-house staff on facilities and process equipment
operation & maintenance
- Perform related duties of a similar nature and complexity as
required
- Liaison between engineering, manufacturing and quality to
identifying and resolving quality and compliance related
issues
- Identifies and implements effective commissioning and
validation, and support the development, qualification, and ongoing
quality support of facilities to meet or exceed internal and
external requirements
- Act as an effective team member in supporting quality
disciplines, decisions, and practices
- Apply sound, systematic problem-solving methodologies in
identifying, prioritizing, communicating, and resolving quality
issues
- Assure the development and execution of streamlined quality
systems for the team, which effectively identify and resolve
quality issuesEducationB.S. in Related Chemical Engineering or
Mechanical Engineering preferredExperience
- HVAC and clean utilities design or installation experience
- required to occasionally wear personal protective equipment
including respiratory protection equipment
- Aseptic formulation and filling manufacturing experience
required
- Working with Fermenters and Lyophilizers
- IMA branded equipment preferred
- Biosafety cabinets
- Ability to work independently and cross-functionally in a
dynamic environment
- Ability to draft, edit and complete required qualification and
engineering documentsKnowledge, Skills and Abilities
- Must have working knowledge of biological processes, equipment,
and facilities. Experience with potent compounds or CDC Select
Agent and Toxin regulations a plus
- A minimum of 7 years' experience in a GMP regulated
environment
- Must have exceptional written and oral communication
skills
- Must be familiar with the Microsoft Office suite of
products
Keywords: Grimaldi Staffing Services, Fremont , Senior Plant Engineer Pharmaceutical, Professions , Fremont, California
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